No

No – not before the approval date of the last active substance contained

The most important provisions for the marketing of BP in the transitional period are:

• § 2 Austrian Biocidal Products Act
• Article 89, 93, 95, of the BPR, 
• Article 69 of the BPR in  conjunction with § 12 Austrian Biocidal Products Act

National Regulations/Decrees:
Biocidal Products Act
 

No fees as there is no registration or notification duty for BP under the transitional measures

Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology
email: biozide(at)bmk.gv.at 
Helpdesk: biozide@umweltbundesamt.at 
 

General note: relevant provisions of REACH (SDS, registration of co-formulants, general restrictions, etc.) and CLP (C&L, Art. 45/Annex VIII, etc.) have to be met.
Label and SDS for BP in German language
 

No

Yes

A completeness check is performed within 45 days from the date of receipt of the application.
A permit to place on the market is granted within 60 days after the date of submission of the complete application

The Law for the Protection from Harmful Impact of the Chemical Substances and Mixtures;

The Ordinance on the form and content of the documents

The fees are determined by the Fee Tariff 

BGN 920 for a single product
BGN 1450 for a family 
BGN 50 for an administrative change (for a single product or family)
BGN 150 for a minor change (for a single product or family)
BGN 350 for a major change (for a single product or family)
 

1. Data for the unified identification code under Art. 23 of the Law for the Trade Register and the Register for legal persons not-for-profit, or a document for an equivalent registration. 
2. Proof of compliance with Art. 95 (2) of the BPR;
3. Technical dossier (including efficacy tests) of the product/family;
4. Safety data sheets for the biocidal product, active substance(s) and co-formulants, prepared according to the requirements of Annex II of REACH; 
5. Proof of the fee payment;
6. The (draft) label of the biocidal product.
    

MINISTRY OF HEALTH
5 Sveta Nedelya Sq.
1000 Sofia
Bulgaria
e-mail: biocides (at) mh.government.bg

https://www.mh.government.bg/bg/helpdesk-biocidi/
 

In Bulgarian: technical dossier, SDS of the biocidal product and label

The declaration of compliance with Article 95, efficacy tests and other SDSs (AS/co-formulants) can be submitted in English.
 

The Ministry of Health, in accordance with the legal requirements, maintains a Register of authorized biocides.

No

Yes, for all PTs

The application for authorisation needs to be submitted at the latest 60 days before the active substance approval date. 

Article 89 and 93 of the BPR

The BPR and national laws (OG 39/13, 47/14, 115/18, 62/20 )
 

EUR 200 per application
There is no annual fee.
Ordinance on fees (OG 154/2022) is applicable also  to national fees paid for authorisations granted under the BPR.
 

Available at Upis biocidnih pripravaka u registar

Ministry of Health, Ksaver 200a, 10000 Zagreb, Croatia
biocidi (at) miz.hr

Application, draft label, SDS – in Croatian
Proof of the Article 95 compliance, efficacy tests and other supporting documents – in English
 

Use of the national electronic system is required.

Once the webform has been completed, the generated document needs to be printed, signed and sent to Ministry of Health. Documents uploaded via the webform do not need to be printed.
 

Yes, for all PTs

No

The notification needs to be submitted 15 days before the biocidal product is placed on market of the Czech Republic.

Art 89 and 93 of the BPR.

§13 and § 14 of Act 324/2016 Coll. (Act on Biocides)
 

CZK 1500 per notification, for one biocidal product. 

• Administrative data
• Identity of biocidal product
• Proposed labelling
• Proposed material safety data sheet
• Efficacy data for the claimed use
• If necessary, additional documents, e.g. letter of access to efficacy data.
   

Ministry of Health of the Czech Republic
biocidy (at) mzcr.cz
 

Czech (in exceptional cases English is acceptable)

A notification must be submitted via the information system.

Brief instructions for submitting notifications:

1. Create a company account according to the instructions available at the abovementioned website. Within one company account, more user accounts may be created, with different privileges.
2. Notification submission: Administrative data should be filled in the information system. Proposed labelling, proposed MSDS and efficacy data should be attached as a PDF or Word document.
3. After submitting, the system sends to the registered email address a request to pay an administrative fee. The fee must be paid in 15 days.
4. After the fee is paid, the notification is subject to completeness and compliance check. New data or amendments may be requested via the system. The user will be notified about this via an email message.
5. Re-submission can be done by opening a notification and clicking on the button “Additional data”.
6. After the notification is accepted, confirmation will be sent to the postal address (companies located in the Czech Republic will receive an electronic version via the DataBox system, foreign companies will receive a letter by post).
    

Yes, for all AS/PTs. 
Biocidal products need to be registered during the transitional period in accordance with the Estonian Biocides Act.

No

Article 89 and 93 of the BPR

National Regulation: Estonian Biocides Act 
 

• From 01.06.2023 new fees apply:
  Registration fee: EUR 400 EUR per single biocidal product, or family.
  Fee for a change  (other than administrative) of the existing registration: EUR 150 per registration certificate.
  Fee for an administrative change of the existing registration: EUR 50 per registration certificate.
  he national regulation on fees is represented by the State Fees Act

Information on the data requirements is available on the Health Board webpage.
The Estonian Biocides Act.
 

Terviseamet/Health Board; Department of Chemicals Safety 
Paldiski mnt 81, 10617 Tallinn 
bpr (at) terviseamet.ee
 

The application may be submitted in English, but the labelling information according to CLP needs to be in Estonian.

For biocidal products, Article 45 of CLP applies. Questions related to Article 45 notifications should be sent to the CLP Helpdesk: clp (at) terviseamet.ee

Yes, a notification is required for all PTs, for products marketable under Article 89 of the BPR.
No notification is required for products marketable under Article 93 of the BPR.

Products containing a combination of an Article 89 and an Article 93 active substance (AS), and products containing a combination of an AS included in the Review Programme and one that is not included, or a new active substance, are not marketable in Germany during the transitional period.
 

No

Article 89 of the BPR in conjunction with German Chemicals Act (ChemG) §28(8)
Article 93 of the BPR in conjunction with ChemG §28(11)
German Biocide Law Implementation Ordinance (ChemBiozidDV) 

The notification is free of charge.

General information on fees in Germany:
German Special-Fees Ordinance – BMU (Besondere Gebührenverordnung BMU - BMUBGebV)

General information on prerequisites and requirements:

• Transitional measures for biocidal products containing "existing active substances" in Germany [en]
• Notification Procedures for Biocidal Products [en]

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin - Bundesstelle für Chemikalien (BAuA)
Federal Institute for Occupational Safety and Health - Federal Office for Chemicals 

Friedrich-Henkel-Weg 1-25
D-44149 Dortmund
mail: chemG (at) baua.bund.de
technical questions regarding the notification procedure can be directed to chembioziddv (at) baua.bund.de 

German

The notification platform

Yes, for all PTs

Yes, only for PT 1-5, 18-19

For the submission of applications for new authorisations and for changes of existing authorisations: 3 months prior to the date of approval of the last active substance/PT combination contained in the product.

Article 89 and 93 of the BPR

National Decree: Governmental Decree No. 316/2013 (VIII.28.) 
 
 

Varies and adds up per PT: HUF 96,000 – 429,500

Annual fees: No  
 

Annex 2 of the Governmental Decree No. 316/2013 (VIII.28.)

National Public Health Center, 1097 Budapest, Albert Flórián út 2-6., Hungary 

email: biocide.helpdesk (at) nnk.gov.hu
 

Hungarian language.

The use of the official electronic system named ‘Hivatali Kapu’ is mandatory

Yes, for all PTs

Yes, for all PTs

Art. 89 and 93 of the BPR

The BPR enacted into Irish Law by Statutory Instrument No. 427 of 2013. 
 

Fees for all National Notification Applications can be found at: 
PRCD - Fees 
 

Data requirements for all National Notification Applications can be found at: 
PRCD - National Notification Applications
 

Department of Agriculture, Food and the Marine. 
Biocides helpdesk: biocides(at) agriculture.gov.ie
National Notification Applications: biocide-notifications (at) griculture.gov.ie

English

Full details on Biocides are available at: 
PRCD - Biocides 
 

No

Set out in DPR (Decree of President of the Republic) on  6/10/1998 N 392
Applications for PMC authorisation may be submitted until 1 year before the active substance approval date.
 

• Art 89 (2) and Art 93 of the BPR
• DPR (Decree of President of the Republic) on  6/10/1998 N 392
   

Vary from EUR 95 (Release of free sale certificates) up to EUR 3,827.60

• Further information on fees.

ational Regulations/Decrees are available at:

Decreto del presidente della repubblica 06 ottobre 1998, n. 392

Presidi medico-chirurgici
 

Ministry of Health-Medical Devices and Pharmaceutical Services
Department-Biocides and Cosmetics -Office 8
Ribotta 5
00144 Roma
Biocidi (at) sanita.it
Phone number   +39-659-942-520

Italian or English

Applications need to be submitted via email at: dgfdm (at) postacert.sanita.it

No

Yes

The Latvian national registration system applies in accordance with the deadlines specified in Art 89(2) of the BPR.

Article 89 and 93 of the BPR

Regulation No. 628 of the Cabinet of Ministers of the Republic of Latvia on requirements regarding the handling of biocides of 27 August 2013
 

EUR 60.20 per single product and EUR 32.55 per additional  product within a biocidal product family. The fee applicable for change applications is 65.10 EUR. VAT needs to be added to the abovementioned fees. 

Fees may be subject to changes.

1. An application with the required information about the biocidal product
   • Application form
2. An example of the biocidal product label, in Latvian, compliant with the CLP requirements and Article 69 of the BPR;  
3. A safety data sheet (SDS) in Latvian, in accordance with REACH requirements;
4. Declaration of compliance with the obligations under Article 95 of the BPR. 
    

Latvian Environment, Geology and Meteorology Centre (LEGMC)
Maskavas Str. 165, Rīga, LV-1019

biocides (at) lvgmc.lv
Phone: + 371 67770023
 

The application form and the declaration of compliance with Article 95 can be submitted in Latvian or English. The example of the biocidal product label and the SDS needs to be submitted in Latvian.

For biocidal products, Article 45 of CLP applies. A chemical report and the SDS needs to be submitted to LEGMC. More information is available here. Questions regarding the report can be sent to LEGMC via e-mail: chemdb@lvgmc.lv.

Yes, for all AS/PTs, a notification is required prior to the placing on the market.

No

Notifications can be submitted until the date of approval of the last AS/PT combination contained in the product.

Article 89 and 93 of the BPR

National law: 

• Loi modifiée du 4 septembre 2015 relative aux produits biocides

EUR 100 per product notification (one BP per notification only).

• Notification form; 
• SDS; 
• Article 95 compliance declaration(s); 
• Label, 
• Excel-sheet listing uses under PTs; 
• Efficacy test reports – only required for PTs 1-4

Mise sur le marché de produits biocides
 

Ministère de l'Environnement, du Climat et du Développement durable Administration de l’environnementUnité Substances chimiques et produits
1, avenue du Rock'n'Roll
L - 4361 Esch/Alzette
 

French, German, or English

No

Yes, for all PTs

Applications for new authorisations under transitional law and major changes under transitional law can be submitted up to 78 weeks before the approval date of the last active substance/PT combination contained in the product to be authorised. 

Article 89 and 93 of the BPR,
National Regulations/Decrees :
Wet gewasbeschermingsmiddelen en biociden

Vary and starting from EUR 965 for
new derived authorisation, and 
starting from EUR 17,850 for new regular authorisations 
The annual fee for 2023 corresponds to EUR 1,325.

Fees vary and are updated every year. Detailed information on fees is available at: 
Tariffs | Biocides | Board for the Authorisation of Plant Protection Products and Biocides (ctgb.nl)
 

Information on data requirements can be found at:
Application under transitional legislation | Biocides | Board for the Authorisation of Plant Protection Products and Biocides (ctgb.nl)
Assessment framework and manuals | Biocides | Board for the Authorisation of Plant Protection Products and Biocides (ctgb.nl)
 

Ctgb
P.O. box 8030
Zip code: NL 6710 AA Ede 
pone +31 317 - 471 810
servicedesk (at) ctgb.nl
 

English or Dutch. Instructions for use in Dutch.

Information on the periods of grace is available at Grace period biocidal products on Board for the Authorisation of Plant Protection Products and Biocides website (ctgb.nl)

Mo

Yes, for all PTs

For the submission of applications for new authorisations, at least 6 months prior to the date of approval of the last active substance/PT combination contained in the product.

Article 89 of the BPR, Article 93 of the BPR National Regulations/Decrees:  Act of 9 October 2015 on Biocidal Products 

Polish Act on biocidal products  
 

• Opłaty [pl]  
• Fees  [en]  

• Wymagania oraz wniosek [pl]
• Requirements and application form [en]
   

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C 02-222 Warszawa, Polska

Email: pb (at) urpl.gov.pl
 

Polish

Only in case of efficacy reports: Polish or English
 

Submission of application documents to the Polish Office:

Hard copies (originals or certified copies)

1. Personally, to the venue of the Office
2. By post/ courier

Documents signed electronically through the Polish electronic platform for communication called ePUAP. 
Electronic address of ePUAP, for our Office is: /URPLWMiPB/SkrytkaESP 
More information concerning this means of communication is available here.

No

Yes

The complete application must be submitted at least 3 months before the approval date of the active substance.

Art 89 (2) and Art 93 of the BPR

Order 10/11/368/2010

 

The fees for placing biocidal products on the market are found in the Order 870/1170/98/2017

The application documents are specified in Art. 4(1) of the Order 10/11/368/2010

The Technical Secretariat of the National Commission for Biocide Products (ST-CNPB)
INSP, etaj 2, camera 219
Str. Dr. Leonte Anastasievici, nr. 1-3, sector 5, Bucuresti, 050463, Romania
e-mail: biocide (at) insp.gov.ro;
Fax: 004021 311 86 22

Romanian

Yes, for all PTs

Yes, for all PTs

The submission deadline corresponds to the day before the approval date of the latest active substance in a biocidal product.

§ 20 of the Slovak Biocidal Act No. 319/2013

• Paper application fee EUR 300
• Electronic application fee EUR 230
• Annual fee per product EUR 150

Item 153a of the Act on Administrative Fees
 

§ 20 item 2 of the Slovak Biocidal Act; see Application form
 

Ministry of Economy of the Slovak Republic Centre for Chemical Substances and Preparations
Mlynské nivy 44/a,
827 15 Bratislava 212

biocides (at) mhsr.sk
+421 907 957 583
 

See Application form

Crossborder e-submissions

Yes, for all AS/PTs

No

Notifications can be submitted until the date of approval of the last AS/PT combination contained in the product

• Article 89 and 93 of the BPR
• Decree implementing Regulations (EU) concerning the making available on the market and use of biocidal products

• Notification form;
• Registration in other countries;
• Article 95 compliance declaration(s);
• Label,
• SDS;
• Efficacy test reports – EN language is also possible

Ministry of Health
Chemicals Office of the Republic of Slovenia
Ajdovščina 4
1000 Ljubljana
Slovenia
Tel: +386 1 400 60 51
e-mail: biocidi.uzk (at) gov.si

Slovenian

Application can be sent also at: gp-ursk.mz (at) gov.si

Yes – all PTs

Products Register - Kemikalieinspektionen
 

Yes – for PT 8, 10, 14, 15, 16, 17, 18, 19, 20, 21 and for certain types of products in PT 2, 9 and 12.

Swedish rules during transitional period - Kemikalieinspektionen
 

No legal deadlines in national legislation. 

An application is usually processed approximately within one year after the fee was paid, unless any additional information is requested.

The prospective applicants are welcome to contact the Swedish Chemicals Agency preferably one year before the submission of the application.
 

Article 89 and Art. 93 of the BPR

National Regulations: 
Pesticide Ordinance (2014:425)
KIFS 2022:3 - Pesticides Regulations
 

Basic fees vary from SEK 8000 up to SEK 300 000 (additional fees may apply).

The annual fee for an authorised chemical biocidal product is 5.5 % of the sales value.

Application fees for biocidal products - Kemikalieinspektionen

Pesticide Fees Ordinance (2013:63)
 

The data requirements are listed in the application forms.

Application forms and guides for biocidal products - Kemikalieinspektionen
 

Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg

E-mail: kemi (at)kemi.se

Telephone: +46 8 519 41 100
Helpdesk: +46 8 519 41 111

Ask the Swedish Chemicals Agency - Kemikalieinspektionen
 

Swedish or English

Application forms and other documents can be found here:
Apply for authorisation for biocidal products - Kemikalieinspektionen 

A Letter of Access (LoA) is needed to prove that an applicant is   entitled to use documentation in support of a product application:
Guidance on Letter of Access - Kemikalieinspektionen

A registration certificate is needed for the authorisation holder.